Comparison of clinical outcomes after combined therapy of bevacizumab intravitreal injection and topical diclofenac with bevacizumab intravitreal injection alone in diabetic macular edema
Comparison of clinical outcomes after combined therapy of bevacizumab intravitreal injection and topical diclofenac with bevacizumab intravitreal injection alone in diabetic macular edema
Design
An open-label randomized clinical trial with parallel groups and phase 3 that will be conducted on 50 patients.Patients will be assign to one of the intervention or control groups using the block randomization method, based on the generated-computer numbers by the random allocation software.
Settings and conduct
In this study, patients with non-proliferative diabetic retinopathy and diabetic macular edema in Urmia Imam Khomeini Hospital will be included. Patients in both intervention and control groups will receive standard treatment. In the intervention group, in addition to the standard treatment, diclofenac 1% topical drops will be prescribed. The study will be done as open label study.
Participants/Inclusion and exclusion criteria
In this study, 50 patients over 18 years of age with non-proliferative diabetic retinopathy and diabetic macular edema will be included. Patients with glaucoma, history of laser therapy, patients with media opacity, infection and inflammation of the anterior segment of the eye will not be included in the study.
Intervention groups
All patients will undergo standard treatment, which includes intravitreal injection of 1.25 mg of bevacizumab at the first visit and in the first, second and third months. Patients in the control group will receive standard treatment only. Patients in the intervention group, in addition to receiving the standard treatment will take 1 drop of topical diclofenac 1% 4 times a day.
Main outcome variables
Macula central thickness ; Visual acuity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220423054625N1
Registration date:2023-10-28, 1402/08/06
Registration timing:prospective
Last update:2023-10-28, 1402/08/06
Update count:0
Registration date
2023-10-28, 1402/08/06
Registrant information
Name
Ghader Motarjemizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3365 0824
Email address
gmotarjemizadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-21, 1402/09/30
Expected recruitment end date
2024-04-19, 1403/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clinical outcomes after combined therapy of bevacizumab intravitreal injection and topical diclofenac with bevacizumab intravitreal injection alone in diabetic macular edema
Public title
Investigating the effect of topical diclofenac in diabetic macular edema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic patients with non-proliferative diabetic retinopathy and diabetic macular edema
Age over 18 years
Exclusion criteria:
Glaucoma patients
Patients with a history of laser therapy
Patients with significant media opacity
Infection and inflammation of the anterior canine of the eye
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to one of the intervention or control groups using computer-generated numbers produced by the Random allocation software. Thus, in this software, the number of groups and the total sample size will be entered, and then the "randomization” will be implemented in the block section. Then, the computer-generated number list will be given to the physician, and the physician will assign patients to groups according to the determined order by the software for entry into one of the groups. Thus, the randomization process will continue until the final sample size is reached.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Imam Khomeini University hospital- Urmia University of Medical Sciences
Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema
Primary outcomes
1
Description
Macula central thickness
Timepoint
Before the intervention and one and three months after the intervention
Method of measurement
Optical Coherence Tomography (OCT)
2
Description
Visual acuity
Timepoint
Before the intervention and one and three months after the intervention
Method of measurement
Snellen chart
Secondary outcomes
1
Description
Intraocular pressure
Timepoint
Before the intervention and one and three months after the intervention
Method of measurement
Tonometer
Intervention groups
1
Description
Intervention group: Patients in the intervention group, in addition to receiving the standard treatment, which includes intravitreal injection of 1.25 mg of bevacizumab at the first visit and in the first, second and third months, will take 1 drop of topical diclofenac 1% 4 times a day.
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group will receive the only standard treatment that includes intravitreal injection of 1.25 mg bevacizumab at the first visit and in the first, second and third months.